Spinal disc herniation, a common ailment, often induces pain, as well as neurologically and physiologically debilitating processes for which relief becomes paramount. If conservative treatments fail, the more drastic measures of discectomies and spinal fusion may be indicated. The later treatment, while providing short term relief, often leads to excessive forces on facet joints adjacent to the fusion and creates further problems over time. Drastic treatments are usually unable to restore normal disc function. The loss of disc function has led to a number of disc prosthesis that attempt to provide natural motion.
The literature documents that the instantaneous axis of rotation (IAR) during sagittal rotation of the superior vertebra with respect to the inferior vertebra of a Functional Spinal Unit (FSU) in the cervical spine moves significant distances during flexion and extension of the spine (Mameren H. van, Sanches H., Beursgens J., Drukker, J., “Cervical Spine Motion in the Sagittal Plane II: Position of Segmental Averaged Instantaneous Centers of Rotation-A Cineradiographic Study”, Spine 1992, Vol. 17, No. 5, pp. 467-474). This motion varies widely between functional spinal units on an individual spine and between individuals and depends on age, time-of-day, and the general health and condition of the intervertebral discs, facet joints and other components of the FSU and spine. A moving IAR means that the superior vertebra both rotates and translates while moving with respect to the inferior vertebra of an FSU. Natural spinal motions place severe requirements on the design of a prosthetic disc; simple rotational joints are not able to meet those requirements.
In addition, motion coupling between axial and lateral bending and other functional spinal units involved in the overall spinal motion increases the complexity and difficulty in developing a prosthetic disc replacement that realizes natural spinal motion. The complex facet surfaces in an FSU significantly influence and constrain sagittal, lateral and axial motions. The orientation of these facet surfaces vary with FSU location in the spine and induce wide variations in motion parameters and constraints. The complex motion of a superior vertebra with respect to the associated inferior vertebra of an FSU, certainly in the cervical spine, cannot be realized by a simple rotation or simple translation, or even a combination of rotation and translation along a fixed axis, and still maintain the integrity and stability of the FSU and facet joints.
One advantage of a general motion spatial mechanism as a disc prosthesis, as described in this application, is that it solves the complex, challenging motion problem posed by nature for disc prosthesis and offers a scalable mechanism for disc replacement without loss of general motion capabilities in the FSU.
Researchers have engineered various spinal disc prosthetic devices that attempt to mimic the natural FSU motions. For example, U.S. Pat. No. 6,733,532, utilizes a cylindrical arrangement of leaf springs (bellows) with a central cushion that provides a non-linear compression response similar to a natural FSU. However, such a design can be limited to the lumbar region of the spine and may not be stable under lateral spinal forces. Another example is U.S. Pat. No. 6,579,321 which utilizes a helical spring with central cushions seated on support balls. This device appears unable to provide lateral or sagittal linear displacements, which can limit motion when implanted in a natural FSU. A further example is U.S. Pat. No. 5,827,328, which provides a spinal disc prosthesis having multiple springs with adjustable platforms that fit within the vertebrae of a natural FSU. However, the size constraints of the device can limit implantation to the lumbar FSU region, and may still require excessive vertebral bone loss to facilitate implantation, even in the lumbar region of a spine.
Other researchers have also attempted to design a successful intervertebral disc for years. Salib et al., U.S. Pat. No. 5,258,031; Marnay, U.S. Pat. No. 5,314,477; Boyd et al., U.S. Pat. No. 5,425,773; Yuan et al., U.S. Pat. No. 5,676,701; and Larsen et al., U.S. Pat. No. 5,782,832 all use ball-and-socket arrangements fixed to the superior and inferior plates rigidly attached to the vertebrae of an FSU. However, these designs limit motion to rotation only about the socket when the two plates are in contact. As the literature points out (Bogduk N. and Mercer S., “Biomechanics of the cervical spine. I: Normal kinematics”, Clinical Biomechanics, Elsevier, 15(2000) 633-648; and Mameren H. van, Sanches H., Beursgens J., Drukker, J., “Cervical Spine Motion in the Sagittal Plane II: Position of Segmental Averaged Instantaneous Centers of Rotation-A Cineradiographic Study”, Spine 1992, Vol. 17, No. 5, pp. 467-474), this restricted motion does not correspond to the natural motion of the vertebrae, even for sagittal plane motion, much less for combined sagittal, lateral and axial motion. Further, when the two plates, as described in the cited patents, are not in contact, the devices are unable to provide stability to the intervertebral interface, which can allow free motion and lead to disc related spondylolisthesis, FSU instability and excessive facet loading.
As a further elaboration on the many ball-and-socket configurations, consider Salib et. al. (U.S. Pat. No. 5,258,031) as an example of previous efforts to address this problem. The Salib ball-and-socket arrangement only provides 3 independent axes of rotation and no translation when engaged.
During complex motions of an FSU, the superior vertebra, in general, requires translation along three independent directions. A sliding ovate structure in an oversized socket cannot perform such general translation motions, either, as it must engage in a trajectory dictated by its socket's geometrical surface and does not change the deleterious effects that may occur on the facet joints of the unit. The current invention overcomes these deficiencies of prior art devices by providing a full 6 degrees-of-freedom throughout the motion space of the FSU. In a preferred embodiment, the subject invention is also able to provide shock absorption, static compression and extension load bearing, as well as some torsion load bearing from a strong, flexible, corrugated boot covering.
The Cauthen rocker arm device (U.S. Pat. Nos. 6,019,792 and 6,179,874) appears to have similar motion and instability limitations as do the freely moving sliding disc cores found in the Bryan et al. patents (U.S. Pat. Nos. 5,674,296; 5,865,846; 6,001,130; and 6,156,067) and the SB Charité™ prosthesis, as described by Büttner-Jantz K., Hochschuler S. H., McAfee P. C. (Eds), The Artificial Disc, ISBN 3-540-41779-6 Springer-Verlag, Berlin Heidelberg New York, 2003; and U.S. Pat. No. 5,401,269; and Buettner-Jantz et al. U.S. Pat. No. 4,759,766) devices. In addition, the sliding disc core devices of the Bryan et al. and SB Charité™ devices do not permit natural motion of the joint for any fixed shape of the core.
When the FSU extends, the prosthesis's sliding core, in some cases, generates unnatural constraining forces on the FSU by restricting closure of the posterior intervertebral gap in the FSU. In any case, the core does not mechanically link the upper and lower plates of the prosthesis and has no means of maintaining the intervertebral gap throughout the range of motion. Such conditions inevitably contribute to prosthetic disc spondylolisthesis. In general, unconstrained or over-constrained relative motion between the two vertebral plates in a prosthetic disc contributes to FSU instability over time.
Further, current prosthetic disc technology is able only to minimally and rigidly support static loading. For example, load bearing and shock absorption in the SB Charité™ design and others (e.g. Bryan et al., U.S. Pat. No. 5,865,846) rely on the mechanical properties of the resilient, ultra-high-molecular-weight polyethylene core to provide both strength and static and dynamic loading. The rigidity of the sliding core appears to offer little energy absorption and flexibility to meet the intervertebral gap requirements during motion, and most likely generates excessive reaction forces on the spine during flexion, forces that potentially produce extra stress on facet joints and effect mobility.
With respect to the lower vertebra in an FSU, all possible, natural loci of motion of any four non-planar, non-collinear points located in the superior vertebra define the natural workspace of the FSU. This workspace varies from FSU to FSU on the spine, creating considerable spinal disc prosthesis design problems.
The FSU workspace boundary is dictated by the sagittal, lateral and axial angle limits reported in the literature (Mow V. C. and Hayes W. C., Basic Orthopaedic Biomechanics, Lippincott-Raven Pub., N.Y., 2nd Addition, 1997). However, these angle limits do not reveal the underlying complex motion between two vertebrae in an FSU. The study by Mameren H. van, Sanches H., Beursgens J., Drukker, J., “Cervical Spine Motion in the Sagittal Plane II: Position of Segmental Averaged Instantaneous Centers of Rotation-A Cineradiographic Study”, Spine 1992, Vol. 17, No. 5, pp. 467-474 demonstrates this complexity in the cervical spine, even when the motion is restricted to flexion and extension. The subject invention is able to accommodate a broader range of motions, since it moves freely with 6-degrees-of-freedom (DOF) within the angle limits reported for all axes.